SINCLAIR ORAL RINSE— 510(k) K053166

Name: FDA 510(k) clearance K053166
Creator: U.S. Food and Drug Administration
Published: 2006-05-17

Substantially Equivalent

Sinclair Pharmaceuticals Limited

FDA 510(k) clearance K053166 for SINCLAIR ORAL RINSE, Substantially Equivalent on 2006-05-17. Applicant: Sinclair Pharmaceuticals Limited. Device class: 2.

Clearance details

Applicant: Sinclair Pharmaceuticals Limited
Product code: Code NTO
Device class: Class 2
Regulation: 21 CFR 872.5580
Advisory panel: Dental
Date received: 2005-11-14
Decision date: 2006-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Godalming, Surrey, GB

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